Abatacept Wins Its Third FDA Indication

The US Food and Drug Administration has approved the use of modified antibody abatacept (ORENCIA, Bristol Myers Squibb), for the treatment of Psoriatic Arthritis in adults.

This is abatacept’s second approval in less than a month, and third since its initial approval in 2005. It received a green light from the FDA on June 8^th to be administered in subcutaneous injection in patients ages 2 and up for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis, and was first approved more than a decade ago for the treatment of rheumatoid arthritis.

The most recent approval was based on results from two randomized, double-blind, placebo-controlled trials in which abatacept improved disease activity in both TNF-native and exposed patients with high disease activity, high tender and swollen joints, and a disease duration of more than seven years.

The two trials, named PsA-I and PsA-II, assessed 594 adult patients who had Psoriatic Arthritis despite prior treatment with DMARD therapy, and who also had one qualifying psoriatic skin lesion of at least 2 centimeters in diameter.

The primary endpoint of both studies was the proportion of patients achieving ACR 20 response at week 24.

A higher proportion of patients treated with abatacept achieved an ACR20 response at week 24 compared to placebo — 47.5% versus 19% and 39.4% versus 22.3%, respectively. Responses were seen regardless of prior anti-TNFi treatment and regardless of concomitant non-biologic DMARD treatment. Improvements in enthesitis and dactylitis were seen with abatacept treatment at week 24.

The safety profile of abatacept was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis.

Abatacept should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic rheumatoid arthritis therapy, such as anakinra, according to a BMS statement.

“This approval underscores the efficacy of ORENCIA in adult patients with active Psoriatic Arthritis, who have been in need of new treatments,” said Brian J Galvin, Vice President, ORENCIA Development Lead at Bristol-Myers Squibb.